FDA QMSR: practical answers to the most common industry questions.
Discover how the increased use of computerized systems and new technologies like AI and Machine Learning are reshaping Computerized System Validation.
93% of companies implement AI, but only 33% of employees know. The gap isn’t technology—it’s how organizations manage change.
The FDA QMSR Final Rule aligns 21 CFR 820 with ISO 13485:2016. Learn what changes and how medical device manufacturers should prepare.
Commission Implementing Regulations (EU) 2025/2091 and 2025/2154 will make GMP compliance legally binding for veterinary medicinal products.
Quality by Design (QbD): building quality from the start with QTPP, CQAs, and CPPs—now powered by AI, ML, and Digital Twins to transform Life.
From data integrity to AI: the new EU GMP guidelines set a higher standard for compliance in the life sciences industry.
Pharma faces new regulations driving eco-friendly practices and ESG compliance for a sustainable future.
Learn why Software as a Medical Device development needs a Quality by Design approach to ensure safety, compliance, and patient trust
CSA: the future of validation in life sciences—smart, risk-based, and patient-focused
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